E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients will be recruited from out-patient clinics treating opioid dependent patients with buprenorphine or methadone maintenance therapy. Patients will be screened for ADHD symptoms. Based on the screen results, patients will undergo medical and psychiatric assessment to identify those meeting the criteria for adult ADHD. Patients diagnosed with comorbid ADHD and opioid dependence will then be randomized into atomoxetine and placebo study groups.
|
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064104 |
E.1.2 | Term | ADHD |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To estimate the efficacy of atomoxetine when treating ADHD in patients with comorbid opioid dependence. |
|
E.2.2 | Secondary objectives of the trial |
1. To determine the impact of ADHD symptoms on the psychosocial functioning and quality of life in patients with comorbid ADHD and opioid dependence, by assessing possible differences between pharmacological treatment groups. 2. To determine the impact of ADHD on the outcome of opioid maintenance therapy, by assessing possible differences between pharmacological treatment groups.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Study inclusion requires patients to meet DSM-IV criteria for ADHD in childhood and adulthood as well as opioid dependence. Patients must have been committed to opioid maintenance therapy for at least six months prior to study entry. |
|
E.4 | Principal exclusion criteria |
Exclusion criteria are an unstable medical or psychiatric condition, pregnancy and nursing or a known sensitivity to atomoxetine. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
7.1 PRIMARY EFFICACY MEASURE We will rate changes in ADHD symptomatology during pharmacotherapy using CAARS (Conners Adult ADHD Rating Scales; Conners et. al., 1999). An improvement in CAARS scores of 30 % or more is considered significant.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |